Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children
- Conditions
- PregnancyCovid-19
- Interventions
- Other: no intervention
- Registration Number
- NCT04432779
- Lead Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Brief Summary
This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.
- Detailed Description
All pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. Children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother.
In positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. Persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured.
Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. Follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1362
- For pregnant women, all women who deliver in the CHU St Pierre, with oral consent.
- For children follow up: children born to positive mothers and matched controls after written consent
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women tested positive to SARS-CoV-2 during pregnancy no intervention All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. Follow up end at 1 month post delivery. Newborns from women tested negative no intervention Newborns born to mothers who had no COVID-19 infection during pregnancy or at delivery and who consented the follow up study. These control children will be matched with children from the other group for gestational age and ethnicity. Follow up end at 3 years of age. Women tested negative to SARS-CoV-2 during pregnancy no intervention All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. No follow up after delivery. Newborns from women tested positive no intervention Newborns born to mothers who had a positive nasal swab or a positive serology during pregnancy or at delivery and who consented the follow up study. Follow up end at 3 years of age.
- Primary Outcome Measures
Name Time Method Outcome of pregnancy Up to the delivery Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
- Secondary Outcome Measures
Name Time Method Prevalence of positive serology to SARS-CoV-2 at delivery At the delivery Measure of antibodies in maternal serum at delivery
Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers At 1 month post delivery To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life Up to 1 month post delivery Measure of antibodies in cord blood and at the age of 1 month
Clinical evolution of the children Up to 3 years Occurence of infectious disease, neurological development, growth
To characterize placental alterations related to SARS-CoV-2 infection At the delivery Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy
Transplacental transfer of antibodies to SARS-CoV-2 At the delivery Measure the ratio of cord blood antibodies on maternal antibodies titers
Trial Locations
- Locations (1)
CHU SAINT Pierre
🇧🇪Brussels, Belgium